MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3541358
Medical Device Problem Codes	Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation procedure with a mentor memoryshape breast implant 395cc gel breast prosthesis that ruptured post implantation.Rupture of the patient¿s left breast prosthesis was diagnosed via a physical exam and via mri.As a result, the patient is scheduled to undergo explantation on (b)(6)2024.
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: breast prosthesis rupture.D6b explantation date: (b)(6)2024 mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number:(b)(4).
Additional Manufacturer Narrative
On 06-dec-2024, mentor received additional information about the event: - it was previously reported that the patient was scheduled to undergo explantation on (b)(6) 2024.New information received states that the patient underwent explantation on (b)(6) 2024.The patient had both breast prostheses explanted and they were replaced with mentor memorygel breast implant 255cc gel breast prostheses.- it was found that both breast prostheses were removed intact.The left breast prosthesis did not rupture as was diagnosed via mri.Shell folds were observed on the explanted breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 07-jan-2025, the mentor failure analysis lab received the device for evaluation.On 09-jan-2025, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information, the customer reported an intact implant but with shell folds.The product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the breast implant had parallel lines of shell wear on the anterior view.The parallel lines of shell wear found could have given the appearance of shell folds.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.Avoid creating wrinkles or folds in the device during the implantation or other procedures (e.G., revision surgery).A typical practice is to run your finger around the implant before closing to ensure the implant is lying flat and has no folds or wrinkles.Submuscular placement of the device makes the inspection for wrinkles or folds more difficult.A second product was received (lot #6766096).No adverse events were reported for this concomitant (contralateral) device.Therefore, no further analysis is required.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.H6 investigation findings c22: cosmetic defect.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19811939
• Report Number: 1645337-2024-08671
• Device Sequence Number: 20927754
• Product Code: FTR
• UDI-Device Identifier: 00081317005483
• UDI-Public: (01)00081317005483(11)130909(17)180930(10)6754741
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 3541358
• Device Lot Number: 6754741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 01/07/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female